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Test Number : E20-893
Test Name : NetWorker Expert exam for Implementation Engineers
Vendor Name : EMC
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Exam Title : Dell EMC Certified Expert - Implementation Engineer - NetWorker
Exam ID : E20-893
Exam Duration : 90 mins
Questions in exam : 60
Passing Score : 60%
Exam Center : Pearson VUE
Real Questions : Dell EMC NetWorker Expert Implementation Engineers Real Questions
VCE practice test : Dell EMC E20-893 Certification VCE Practice Test

NetWorker Deployment and Performance Management 15%
- Describe the best practices for NetWorker configuration, sizing, and performance management
- Describe the best practices for planning and configuring resources for backup operations

Integrating NetWorker with Microsoft Products 31%
- Explain NetWorker integration with Microsoft SQL; including configuration, use, and considerations
- Explain NetWorker integration with Microsoft Exchange; including configuration, use, and considerations
- Explain NetWorker integration with Microsoft SharePoint; including configuration, use, and considerations

Integrating NetWorker with Databases and Applications 18%
- Explain NetWorker integration with Oracle; including configuration, use, and considerations
- Explain NetWorker integration with SAP/SAP HANA; including configuration, use, and considerations
- Identify and describe the best practices for integrating NetWorker with MEDITECH

Integrating NetWorker with Virtual Environments 24%
- Describe how to configure and use NetWorker to back up and restore Hyper-V virtual machines
- Describe how to configure and use NetWorker to back up and restore VMware virtual machines
- Explain how to deploy and configure NetWorker Virtual Edition

Integrating NetWorker with Other Dell EMC Products 12%
- Identify and describe the best practices for integrating NetWorker with Data Domain
- Identify and describe the best practices for integrating NetWorker with ProtectPoint



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EMC exam teaching

Design for Regulatory Compliance | E20-893 exam questions and PDF Braindumps

whereas working for Hewlett-Packard’s scientific group, a supervisor noted, “When the obstacles to entry are high, those that overcome them have a strategic competencies.” That adage has remained essential in the context of the ever-changing regulatory methods which are a vital part of bringing a brand new medical device to market.

there was lots debate and consternation, specially lately, about the 510(ok) technique, and there will obviously be alterations going forward. this article proposes a simple shift in the philosophy of how regulatory procedures might engage with the product construction manner and paradigm to produce more suitable efficiency and more predictable effects, in spite of how regulations evolve in the future.

As a product dressmaker, it's commonly less difficult to criticize the manner than to figure out the way to make it work to your expertise. however, there are steps that can also be taken all over the product design phase to make the regulatory process greater useful. Design for regulatory can turn into a strategic talents. this text discusses what design for regulatory’ entails and what it could mean to include regulatory thinking into the design method.

The Regulatory ChallengeWhat does design for regulatory imply? it's a process just like those presently in practice:

  • Design for reliability.
  • Design for manufacturability.
  • Design for electromagnetic compatibility (EMC).
  • Design for testability.
  • each and every of these paradigms brings the area advantage of what is considered a downstream product building pastime into the early design method. The goal is to dispose of surprises late in the product building method that frequently produce poor effects corresponding to expensive reworks, ignored milestones, and sooner or later delays in market introduction and income.

    So how will they beginning? the primary issue to do is to google “design for regulatory.” You’ll locate primarily bits of narrow work on EMC and instant design, and the internet sites of a few regulatory affairs consulting organizations. There are only a few on-line search hits on a way to introduce regulatory considerations into product design and even much less assistance about that manner for medical product design.

    Let’s beginning with the aid of realizing the desires of the regulatory methods. In general, they exist to be sure that safe and valuable items are delivered into the market vicinity with appropriate risk-benefit ratios. each company, designer, regulatory skilled, scientific practitioner, and buyer has this as a standard intention. despite the fact, if here's the case, why are there consistently issues?  The issues originate within the manner regulatory compliance is treated all the way through the construction technique. it is regularly viewed as an afterthought or a essential evil to be Checked for and infrequently gamed on the end of the technique when terrible regulatory feedback is awfully irritating and costly. Even one request for additional information can also be devastating to a company’s plans and monetary well-being. Funding for birth-united statesand small corporations is often tied to regulatory milestones.1

    Some companies take risks, purposely or not, via trying to do the minimal required or cautiously crafting claims in the hope of getting previous FDA. despite the fact these recommendations can also now and again work, evidently they don't lead to predictable success, as a result of they could lead frustrate or anger reviewers. A perceived stream toward a more chance-averse FDA make this approach less more likely to produce a successful outcome.

    So what are you able to do? With current ‘design for …’ approaches, teams consist of the stakeholders who make certain a success execution of the plans. similarly, agencies can include regulatory affairs authorities (or those with huge regulatory adventure) directly into their design teams to make sure that the regulatory considerations and requirements are addressed in planning and subsequent design phases. This strategy encourages the team contributors to use their adventure and abilities to design products and test courses for you to enable the advent of regulatory-competent items.

    The team can also collect the statistics and analysis to assist smooth submissions and optimistically clearance and approvals.as with any good multistep reform method, the first step is to admit that there is an issue and agree that the firm wants to clear up it. although regulatory growth is elaborate to music except a product is close the conclusion of the development technique, the resources to accomplish that both exist already in companies or can be recognized and assigned (or shriveled) obligations early within the project. Any costs involved are limited to the necessary regulatory supplies. There are gigantic discounts to be gained from limiting redesign, additional tests, rounds of regulatory review, and delayed income.

    meant Use and signs for UseThe most essential product facets to agree upon within the beginning of the construction process are supposed use and indications for use. youngsters the accurate definition of these phrases (apart from what is provided in 21 CFR 801.4) is currently below dialogue at FDA and will evolve, they just about refer to what the equipment will do and the way it will be used.companies frequently get to the end of product development and have heated interior discussions with designers, entrepreneurs, and regulatory companies, discovering that the aspects and claims made in submissions do not help the advertising substances. The method of constructing changes and realigning messaging is costly and particularly disruptive to a firm. Having a transparent dialogue and settlement, as well as forming a written documentation up entrance that together with meant use, signs for use, and claims, will add consistency and predictability. The claims form the starting point for submission applications, supply necessities, and drive standards in the product design. Verification and validation trying out and collateral materials, corresponding to consumer documentation and advertising substances, turn into well aligned with claims from the beginning of the method.

    standards and counsel DocumentsIndustry requisites should still be used and referenced anyplace it is acceptable. standards can be a sensitive field within the aggressive marketplace, but they're primary for evaluating and evaluating efficiency. agencies comparable to AAMI have proven that standards can also be with no trouble developed in an open and nonthreatening discussion board and include all events concerned.

    standards allow agencies to successfully consider conformance and hold each and every device to a minimal stage of performance. standards do not stifle innovation however as a substitute channel it against exceeding efficiency and cutting back charges by way of concentrating company efforts. They also allow direct head-to-head comparisons in the market between aggressive items.

    When a design group makes use of necessities and tips documents as design input, the files should provide the minimum requirements. Exceeding the requirements can have market advantages if doing so results in demonstrable benefits. as an instance, IEC 60601-1-11 requires an operating temperature range of 5°–forty°C for transit operable home healthcare medical device. although, there are lots of use environments  use through which this specification may well be surpassed—Fairbanks, AK has a normal low temperature of -28°C in January and Phoenix, AZ has a regular high temperature of above forty one°C in July.

    Designing and trying out to a larger latitude can enable advertising claims of operation in less restrictive environments and will yield client benefits or fewer provider and device failure concerns. These advantages ought to be supported with applicable evidence as required by using the regulatory method.

    When there are distinctive necessities, corresponding to international agency necessities, the regulatory and design capabilities deserve to work collectively to opt for the superset for the product requirements to enable clean introduction into additional markets.

    counsel documents from regulatory companies aren't requirements within the literal feel, however should be handled as specifications and their concepts incorporated as design input. no longer taking tips files critically or assuming that they don't seem to be relevant to a product is a typical and unlucky mistake. If an organization elects now not to observe an purchasable tips or makes use of simplest parts that it considers relevant, it can Boost and help that justification decision early in the design manner. in addition, all and sundry on the group may still be comfy with the decision, while the consequences of trying out to assist the choice should still be integrated into the early regulatory submission drafts.

    Don’t overlook to review draft guidances and seek prepublication drafts that can also provide insight into altering company expectations. despite the fact these drafts may nevertheless be open for feedback or now not yet finalized, they could provide helpful insight into FDA’s current thinking in a particular area. The agency has been accepted to enforce draft ideas. Paying attention to those expectations early on saves time and labor later in the method considering that drafts early in a product development cycle regularly develop into defacto requisites or are included into standards by the time the product is ready for submission.

    Have a Regulatory StrategyOnce the device use and requirements are understood, it's time to work on the regulatory strategy. Early in the design procedure, focus on and consist of the following key items: 

  • Proposed claims.
  • Preliminary guidance for use.
  • Predicate equipment decisions. it is additionally wise to gain the predicate equipment’s 510(okay) filings through Freedom of information Act requests.
  • equipment classification—classification I, II, or III; exempt; 510(ok); or do the claims point towards a PMA?
  • foreign marketing approach and further regulatory agency requirements: CE, fitness Canada, Federal Communications fee, medical health insurance Portability and Accountability Act of 1996.
  • Packaging wants and labeling necessities, including foreign symbols and warnings.
  • comparison trying out, including bench and clinical checking out that is required to guide gigantic equivalence.
  • verify plan to demonstrate conformance to present requisites.adjustments between predicates and requirements, and how the changes (if any) will be represented and supported.
  • 513(g) (request for clinical equipment classification) or preinvestigational gadget exemption (IDE) conferences with FDA to support assist the strategic regulatory direction.
  • the use of off-the-shelf components or technology to be sure their safety and effectiveness with the device.
  • reimbursement method and requirements for aiding records—this can also drive claims and greatly trade the strategic product focal point. while no longer the center of attention of this article, it's an important part of the marketing strategy for any medical product or provider. Create a parallel evaluate manner to make coverage determinations whereas FDA clearance or approval is beneath dialogue.
  • These are extraordinarily important discussions and selections, and it is essential that they be accurately documented. The discussions and factors evaluated that subsequently pressure the selections are only as vital to helping the selections stick and conserving the task from disruptive reanalysis processes.

    The discussions might also carry up important considerations and create an opportunity to alter the design of the product to unravel regulatory issues. Designers should still now not panic or  try to online game the gadget. Most frequently, a company will lose with a methodology that tries to get round regulatory concerns or vague them.

    trust considerations rationally. They can also result in adjustments that can also be effective for the client or create a chance to carry the bar with FDA. as an example, the capability to assemble additional equipment data all through use can enable further markets if correctly distinct and carried out. These types of elements can also also be used production trying out and field provider.evaluation checking out and statistics collection cannot be overemphasized. an organization can create a submission that offers it an competencies over competitors through including dazzling comparative records past that which turned into offered in past submissions. These identical data can then be used for marketing functions, making it elaborate and high priced for competitors to reply once the product is brought into the market and lengthening the hurdles they’ll face when submitting records for a future product.

    accept as true with the pre-IDE assembly and present your design for regulatory compliance case to FDA. helping the agency remember that the gadget is designed to be a proactive a part of the regulatory procedure can support the enterprise gain assist from the group that should be reviewing the submission. The pre-IDE meeting is useful for opting for concerns and establishing allies at FDA.

    put together Submission files all over Product DesignOnce the input requirements and product requirements are complete, the design crew will have a good deal of the suggestions that it needs to create regulatory submissions for all nations in the business plan. despite the fact the check facts are missing, the tables will also be created proforma to be crammed in with the acceptable passing verification and validation information as those checks are accomplished.

    All too often, these files are organized a whole lot later in the system. it is less complicated and less expensive to make alterations early in the process. Regulatory adjustments are no different, apart from that in the past, corporations have hardly ever considered altering products to facilitate less demanding and more finished regulatory approvals. as a substitute, they alter product claims and limit the market capabilities for their device. in the end, this approach is extra costly.developing these documents early enables an organization to determine and fix deficiencies fantastically without difficulty and at reasonable. Early introduction of these documents may additionally also alter the regulatory approach.

    Hazard AnalysisSurprises in the regulatory procedure can commonly be traced lower back to hazard evaluation. For the applications of this article, the term hazard analysis is used as a broad class to consist of failure modes and outcomes evaluation and all different appropriate possibility and hazard analysis strategies as applicable to medical contraptions.

    issues continually come up from the omission of dangers linked to new technologies (corresponding to replacing a cable using wireless technology) or unrealistic scoring of the hazard or its mitigation. even if this effects from a lack of appreciation for new hazards or unquestioning reuse of the evaluation from the old product technology, omitting them may end up in massive concerns.

    This evaluation offers an additional opportunity to design for regulatory as it offers extra input requirements. Product design adjustments probably provide the strongest mitigations and are once in a while the inexpensive. Design adjustments early in the system are tons inexpensive and time-ingesting than creation tweaks. facets may also be added to supply extra protection or robustness to records, and extra features can support in verification for other mitigation projects that can also not be present within the core product features and necessities.

    respectable tips for hazard evaluation is equipped in ISO 14971, and it is often very beneficial to cautiously evaluate the evaluation of predicate instruments.

    conserving and Patenting aspects for CompliancePay particular attention to any elements brought to a product to facilitate the regulatory submission, comparable to these permitting for statistics assortment right through verification or validation trying out, or these mitigating hazards. review of these features and their implementation may find patentable fabric and once again, competitive advantages. Patents don't deserve to be flashy to be advantageous in making it intricate for a competitor to execute its regulatory method. trust any function that has been brought on account of the regulatory assessment or a distinct design element that permits less demanding demonstration of safety or efficacy for protection.

    Design the check ProgramCreating the regulatory plan and prototype submission early allows for some creativity in combining aspects to make the optimal checking out application. for instance, all over the setup trying out phase for a brand new product, trying out of predicate and aggressive products will also be performed with minimal added work and cost. it's effective to understand how the competition performs not best for the regulatory submission, however additionally for product marketing purposes. If a key product performance effect will also be identified and supported in its value to the product or for the customer, FDA may respect it as a requirement for future items submitted by competitors.

    extremely accelerated existence testing and highly accelerated stress screening testing are astonishing methods. youngsters, do not underestimate the value of testing the boundaries right through common efficiency testing.

    A verify program will regularly adhere to the inner and marketed requisites to set test limits. This information is primary for submissions, but while a look at various is set up, it can also be very valuable to continue the trying out to establish design margins and potentially beneficial characterization information. This information can support show the robustness of a design and might permit for an improved certain to the consumer or decrease gathered warranty cost expectations.check failures are inevitable. Fixing concerns which are identified all the way through validation or verification actions offers an additional opportunity to trust the massive photo and consist of regulatory concerns.

    despite the fact EMC has received consideration from the agency (including establishment of a relationship with the FCC), don’t forget that it is also a controversy for the client. EMC testing of aggressive items can yield an realizing of knowledge interactions as well as their product weaknesses. it'll enable design changes that make products extra compatible and assist the client with constructive installing and operation assistance. It might additionally probably provide sales and advertising departments beneficial aggressive information.

    Design groups and FDA SubmissionThe designers have pleasing insight into the product and its know-how. it's an competencies to use this knowledge in drafting selected sections of the submission, expertise descriptions, and comparisons. considering the whole team has been involved in the manner, every person will be proactive and engaged. There is generally sections of the submission that may also be reused directly from product design documents, as a result of they  include aiding fabric similar to drawings.

    Reviewers Are Your FriendsFinally, the reviewer is your chum; the design crew should still trust this commentary too. Make it a main intention to teach your reviewer(s). they have a tremendous workload that consists of numerous items and may now not have the depth of capabilities and competencies to utterly admire your product. consider about assisting a pal take into account this first-rate new product and you’ll have a more robust submission.

    schooling is even more essential if this product introduces a brand new know-how or method. Don’t expect that as soon as it looks on Wikipedia your reviewer could be an expert. as soon as here is based as an working principle, first rate things can ensue. individuals will believe about the way to make the reviewer’s job less difficult via presenting spectacular facts and assisting material. Any new or complicated ideas will be accompanied via awesome trade and peer-reviewed reference fabric. Reviewer-friendly submissions will support you gain allies at FDA.

    ConclusionDesign for regulatory is a useful thought, inspite of future alterations to agency necessities or techniques. other ‘design for…’ paradigms have proven that up-front, early consideration of tasks that are usually carried out at the end of the product development system reduces time to market and fees linked to redesign.despite the fact following the counsel in this article isn't without can charge, doing so is a profitable investment. The construction of a high-quality regulatory approach and the incorporation of regulatory resources into the design technique will make sure fewer surprises and allow for greater productive and potentially easier FDA submissions. This paradigm can additionally yield enhanced aggressive suggestions and product positioning and potentially create a competitive potential in the industry.

    Reference1. Conroy S, “decreased VC dollars capacity New Challenges for Medtech birth-Ups,” MD+DI 32, no. 10 (2010): 18; obtainable from cyber web: http://www.mddionline.com/article/decreased-vc-cash-potential-new-challenges-medtech-beginning-ups.

    invoice Saltzstein is founding father of Code Blue Communications Inc. (Woodinville, WA). 


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